- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03624569
Cardiometabolic Benefits of Potatoes Mediated Along the Gut-Vessel Axis in Adults With Metabolic Syndrome
January 15, 2020 updated by: Richard Bruno, Ohio State University
This study is focused on assessing potential health benefits of daily consumption of potatoes, specifically its resistant starch content (i.e.
nondigestible carbohydrate), on blood vessel and gut health function in adults with metabolic syndrome.
It is expected that the daily consumption of potatoes for two weeks, within a diet that follows the Dietary Guidelines for Americans, will improve blood vessel function in association with decreasing gut permeability ("leaky gut") that results in the absorption of bacterial toxins that reside in the intestine.
Outcomes will therefore support dietary recommendations for potatoes to support vascular and gastrointestinal health.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Cardiovascular disease is a major public health concern in the United States, where it accounts for 1 in 4 deaths every year.
Vascular endothelial dysfunction is an early event leading to cardiovascular disease and can be caused by postprandial hyperglycemia.
Cardiovascular disease is also characterized by metabolic endotoxemia.
Metabolic endotoxemia describes increased circulating levels of gut-derived endotoxin (lipopolysaccharide; a bacterial product derived from Gram-negative bacteria in the intestines) that results from gut barrier dysfunction, a phenomenon that is common in metabolic syndrome.
Studies in animals and humans have shown that consumption of resistant starch (a type of carbohydrate found in potatoes among other foods) can help to improve vascular and gut health.
This clinical trial will therefore investigate the extent to which potatoes can improve microbiota composition, alleviate metabolic endotoxemia, and improve vascular function.
It is hypothesized that 2-week daily ingestion of potatoes within a diet that meets the Dietary Guidelines for Americans will limit metabolic endotoxemia by decreasing gut barrier permeability and alleviating gut dysbiosis while separately improving vascular function by limiting postprandial hyperglycemia.
This study will address the following objectives: 1) define changes in gut barrier function in association with improved gut microbiota composition, increased fecal short chain fatty acid (SCFA) production, and decreased serum endotoxin, 2) define changes in postprandial glycemic responses and endotoxemia, and 3) define changes in gut hormones that promote glycemic control and changes in markers of oxidative stress in relation to improvements in endothelial vascular function, all following 2-week potato consumption.
To test the hypothesis, all participants will complete a randomized cross-over trial where they will receive a potato or bagel along with a diet that meets the Dietary Guidelines for Americans for 2 weeks.
They will then undergo a 2-h postprandial study to define the influence of potato consumption on vascular function, glycemic control, and endotoxin translocation.
Upon completing the intervention, participants will undergo a gut permeability test, fecal samples will be collected for microbiota composition analysis, and blood samples will be collected to assess endotoxin and inflammatory markers.
Upon successfully completing this study, it is anticipated that chronic consumption of potatoes will be demonstrated to be an effective dietary strategy to reduce metabolic endotoxemia, improve gut health, and improve vascular function.
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Richard Bruno, PhD, RD
- Phone Number: 6142921698
- Email: bruno.27@osu.edu
Study Contact Backup
- Name: Emily Shaw, BS
- Phone Number: 5736737269
- Email: shaw.876@buckeyemail.osu.edu
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43210
- Recruiting
- Ohio State University
-
Contact:
- Richard Bruno, PhD, RD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Fasting glucose 100-125 mg/dL
- Waist circumference >102 cm (men), >88 cm (women)
- Fasting triglyceride >150 mg/dL
- Fasting HDL cholesterol <40 mg/dL (men), <50 mg/dL (women)
- Non-smoker
- Non-dietary supplement user (>1-mo)
- Free of gastrointestinal disorders, cardiovascular disease, cancer
- No recent use of antibiotics or any medications affecting glycemia, lipidemia, or blood pressure
Exclusion Criteria:
- Use of anti-inflammatory agents or probiotics
- Vegetarian, gluten-intolerant, carbohydrate-restricted diet
- Alcohol intake >2 drinks/d
- >7 hours/week of aerobic activity
- Women who are pregnant or lactating or have initiated or changed birth control in the past 3-months
- Taking medications that affect blood sugar, blood pressure, blood vessel health, or inflammation
- High blood pressure or any vascular diseases
- HIV, hepatitis, or blood disorders such as hemophilia
- Gastrointestinal disorders
- Cancer (current or past history)
- Anemia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Sham Comparator: Bagel diet
Bagel consumed daily for 2 weeks
|
A bagel will be consumed daily for 2 weeks.
|
Experimental: Potato diet
Potato consumed daily for 2 weeks
|
A potato will be consumed daily for 2 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Endotoxin
Time Frame: Day 14
|
Fasting serum endotoxin concentration
|
Day 14
|
Vascular endothelial function
Time Frame: Day 14 Postprandial (0, 30, 60, 90, 120 minutes)
|
Area under curve (change from baseline) for flow-mediated dilation of brachial artery
|
Day 14 Postprandial (0, 30, 60, 90, 120 minutes)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fasting Glucose Day 0
Time Frame: Fasting glucose on Day 0
|
Fasting plasma glucose
|
Fasting glucose on Day 0
|
Fasting Glucose Day 14
Time Frame: Fasting glucose on Day 14
|
Fasting plasma glucose
|
Fasting glucose on Day 14
|
Fasting Insulin Day 0
Time Frame: Fasting insulin on Day 0
|
Fasting plasma insulin
|
Fasting insulin on Day 0
|
Fasting Insulin Day 14
Time Frame: Fasting insulin on Day 14
|
Fasting plasma insulin
|
Fasting insulin on Day 14
|
Postprandial Insulin
Time Frame: Day 14 postprandial (0, 30, 60, 90, 120 minutes)
|
Plasma insulin concentration area under curve change from baseline
|
Day 14 postprandial (0, 30, 60, 90, 120 minutes)
|
Postprandial Glucose
Time Frame: Day 14 postprandial (0, 30, 60, 90, 120 minutes)
|
Postprandial plasma glucose concentration area under curve change from baseline
|
Day 14 postprandial (0, 30, 60, 90, 120 minutes)
|
Fasting Endotoxin
Time Frame: Day 0
|
Fasting serum endotoxin concentration
|
Day 0
|
Postprandial Endotoxin
Time Frame: Day 14 postprandial (0, 30, 60, 90, 120 minutes)
|
Postprandial serum endotoxin concentration area under curve change from baseline
|
Day 14 postprandial (0, 30, 60, 90, 120 minutes)
|
Lactulose/mannitol ratio
Time Frame: Day 14, 0-5 hours post-consumption of sugar probes
|
Urinary concentration of the non-digestible sugars lactulose/mannitol
|
Day 14, 0-5 hours post-consumption of sugar probes
|
Sucralose/erythritol ratio
Time Frame: Day 14, 6-24 hours post-consumption of sugar probes
|
Urinary concentration of the non-digestible sugars sucralose/erythritol
|
Day 14, 6-24 hours post-consumption of sugar probes
|
Fecal butyrate
Time Frame: Day 14
|
Fecal concentration of butyrate
|
Day 14
|
Fecal acetate
Time Frame: Day 14
|
Fecal concentration of acetate
|
Day 14
|
Fecal propionate
Time Frame: Day 14
|
Fecal concentration of propionate
|
Day 14
|
Postprandial Cholecystokinin
Time Frame: Day 14 postprandial (0, 30, 60, 90, 120 minutes)
|
Plasma CCK area under curve change from baseline
|
Day 14 postprandial (0, 30, 60, 90, 120 minutes)
|
Postprandial glucagon-like peptide-1
Time Frame: Day 14 postprandial (0, 30, 60, 90, 120 minutes)
|
Plasma GLP-1 area under curve change from baseline
|
Day 14 postprandial (0, 30, 60, 90, 120 minutes)
|
Postprandial Gastric inhibitory peptide
Time Frame: Day 14 postprandial (0, 30, 60, 90, 120 minutes)
|
Plasma GIP area under curve change from baseline
|
Day 14 postprandial (0, 30, 60, 90, 120 minutes)
|
Fasting cholecystokinin
Time Frame: Day 14
|
Fasting plasma concentration of CCK
|
Day 14
|
Fasting GLP-1
Time Frame: Day 14
|
Fasting plasma concentration of GLP-1
|
Day 14
|
Fasting Gastric inhibitory peptide
Time Frame: Day 14
|
Fasting plasma concentration of GIP
|
Day 14
|
Postprandial NOx
Time Frame: Day 14 postprandial (0, 30, 60, 90, 120 minutes)
|
Plasma total nitrite/nitrate area under curve change from baseline
|
Day 14 postprandial (0, 30, 60, 90, 120 minutes)
|
Fasting NOx
Time Frame: Day 14
|
Fasting plasma concentration of nitrite/nitrate
|
Day 14
|
Postprandial Malondialdehyde (MDA)
Time Frame: Day 14 postprandial (0, 30, 60, 90, 120 minutes)
|
Plasma MDA concentration, biomarker of oxidative stress area under curve change from baseline
|
Day 14 postprandial (0, 30, 60, 90, 120 minutes)
|
Fasting Malondialdehyde (MDA)
Time Frame: Day 14
|
Fasting plasma MDA concentration, biomarker of oxidative stress
|
Day 14
|
Fasting Vascular Endothelial Function
Time Frame: Day 14
|
Fasting flow-mediated dilation of the brachial artery
|
Day 14
|
Vitamin C
Time Frame: Day 14
|
Fasting vitamin C concentration, biomarker of oxidative stress
|
Day 14
|
cIMT
Time Frame: Day 14
|
Carotid intima-media thickness
|
Day 14
|
Day 0 weight
Time Frame: Day 0
|
Weight in kilograms
|
Day 0
|
Day 7 weight
Time Frame: Day 7
|
Weight in kilograms
|
Day 7
|
Day 14 weight
Time Frame: Day 14
|
Weight in kilograms
|
Day 14
|
Day 0 height
Time Frame: Day 0
|
Height in centimeters
|
Day 0
|
Day 7 height
Time Frame: Day 7
|
Height in centimeters
|
Day 7
|
Day 14 height
Time Frame: Day 14
|
Height in centimeters
|
Day 14
|
Day 0 waist circumference
Time Frame: Day 0
|
Waist circumference in centimeters
|
Day 0
|
Day 7 waist circumference
Time Frame: Day 7
|
Waist circumference in centimeters
|
Day 7
|
Day 14 waist circumference
Time Frame: Day 14
|
Waist circumference in centimeters
|
Day 14
|
Day 0 diastolic blood pressure
Time Frame: Day 0
|
Diastolic blood pressure
|
Day 0
|
Day 7 diastolic blood pressure
Time Frame: Day 7
|
Diastolic blood pressure
|
Day 7
|
Day 14 diastolic blood pressure
Time Frame: Day 14
|
Diastolic blood pressure
|
Day 14
|
Day 0 systolic blood pressure
Time Frame: Day 0
|
Systolic blood pressure
|
Day 0
|
Day 7 systolic blood pressure
Time Frame: Day 7
|
Systolic blood pressure
|
Day 7
|
Day 14 systolic blood pressure
Time Frame: Day 14
|
Systolic blood pressure
|
Day 14
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, de Ferranti S, Despres JP, Fullerton HJ, Howard VJ, Huffman MD, Judd SE, Kissela BM, Lackland DT, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Willey JZ, Woo D, Yeh RW, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2015 update: a report from the American Heart Association. Circulation. 2015 Jan 27;131(4):e29-322. doi: 10.1161/CIR.0000000000000152. Epub 2014 Dec 17. No abstract available. Erratum In: Circulation. 2015 Jun 16;131(24):e535. Circulation. 2016 Feb 23;133(8):e417.
- DECODE Study Group, the European Diabetes Epidemiology Group.. Glucose tolerance and cardiovascular mortality: comparison of fasting and 2-hour diagnostic criteria. Arch Intern Med. 2001 Feb 12;161(3):397-405. doi: 10.1001/archinte.161.3.397.
- Camire ME, Kubow S, Donnelly DJ. Potatoes and human health. Crit Rev Food Sci Nutr. 2009 Nov;49(10):823-40. doi: 10.1080/10408390903041996.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 15, 2018
Primary Completion (Anticipated)
July 1, 2020
Study Completion (Anticipated)
July 1, 2020
Study Registration Dates
First Submitted
August 2, 2018
First Submitted That Met QC Criteria
August 8, 2018
First Posted (Actual)
August 10, 2018
Study Record Updates
Last Update Posted (Actual)
January 18, 2020
Last Update Submitted That Met QC Criteria
January 15, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018H0265
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
Data will be published as aggregate only.
Data sharing may be possible pending institutional agreements.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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